01-7839. Agency Information Collection Activities; Proposed Collection; Comment Request; Institutional Review Boards

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on FDA’s protection of human subjects recordkeeping and reporting requirements for institutional review boards (IRB’s). IRB’s are groups composed of members of varying backgrounds that are charged with reviewing the ethics and risk/benefit aspects of clinical studies involving human subjects to assure that the rights and welfare of human subjects are adequately protected.

DATES:

Submit written or electronic comments on the collection of information by May 29, 2001.

ADDRESSES:

Submit electronic comments on the collection of information via the Internet at http://www.accessdata.fda.gov/​scripts/​oc/​dockets/​edockethome.cfm. Submit written comments on the collection of information to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane., rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Karen L. Nelson, Office of Information Resources Management (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1482.

SUPPLEMENTARY INFORMATION:

Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility; (2) the accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

Institutional Review Boards—Section 56.115 (21 CFR 56.115) (OMB Control No. 0910-0130)—Extension

When reviewing clinical research studies regulated by FDA, IRB’s are required to create and maintain records describing their operations, and make the records available for FDA inspection when requested. These records include: Written procedures describing the structure and membership of the IRB and the methods that the IRB will use in performing its functions; the research protocols, informed consent documents, progress reports, and reports of injuries to subjects submitted by investigators to the IRB; minutes of meetings showing attendance, votes and decisions made by the IRB, the number of votes on each decision for, against, and abstaining, the basis for requiring changes in or disapproving research; records of continuing review activities; copies of all correspondence between investigators and the IRB; statement of significant new findings provided to subjects of the research; and a list of IRB members by name, showing each member’s earned degrees, representative capacity, and experience in sufficient detail to describe each member’s contributions to the IRB’s deliberations, and any employment relationship between each member and the IRB’s institution. This information is used by FDA in conducting audit inspections of IRB’s to determine whether IRB’s and clinical investigators are providing adequate protections to human subjects participating in clinical research.

FDA estimates the burden of this collection of information as follows:

Table 1.—Estimated Annual Recordkeeping Burden¹

21 CFR Section	No. of Recordkeepers	Annual Frequency per Recordkeeping	Total Annual Records	Hours per Recordkeeper	Total Hours
56.115	2,000	14.6	29,200	4.5	131,400
Total					131,400
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

The recordkeeping requirement burden is based on the following formula: Approximately 2,000 IRB’s review FDA-regulated research involving human subjects annually. The burden for each of the paragraphs under § 56.115 has been considered as one estimated burden. Each paragraph cannot reasonably be segregated from one another because all are interrelated. FDA has about 2,000 IRB’s in its inventory. The 2,000 IRB’s meet on an average of 14.6 times annually. The agency estimates that approximately 4.5 hours of person time per meeting are required to transcribe and type the minutes of the meeting; to maintain records of continuing review activities; and to make copies of all correspondence between the IRB and investigative member records, and written IRB procedures that are approximately five pages per IRB.

Dated: March 23, 2001.

William K. Hubbard,

Senior Associate Commissioner for Policy, Planning, and Legislation.